LABORATORY MEDICINE SERVICE RULES AND REGULATIONS 2016

University of California, San Francisco Department of Laboratory Medicine Zuckerberg San Francisco General Hospital 1001 Potrero Avenue, San Francisco, CA 94110 Style Definition: Heading 2: Indent: Left: 0", Hanging: 0.5", Space Before: 0 pt, No bullets or numbering, Don't keep with next Clinical Laboratory Barbara HallerEberhard Fiebig, MD, PhD, Interim Director Clinical Laboratory: Date of Original: March 2002 Date of Current Revision: September 1, 2016June 20, 2013 Original Prepared by: Eberhard Fiebig, MD Current Revision by: Barbara HallerEberhard Fiebig, MD, PhD Job Title: Director Job Title: Interim Director Approved by: Job Title: Signature: Date: Barbara HallerEberhard Fiebig, MD, PhD Interim Director Implementation Date: Retired: Date: By: Replaced by: LABORATORY MEDICINE SERVICE RULES AND REGULATIONS 2016 Page 1 of 31

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Laboratory Medicine Service Rules and Regulations 2016 September 2016 LABORATORY MEDICINE SERVICE RULES AND REGULATIONS TABLE OF CONTENTS LABORATORY MEDICINE SERVICE ORGANIZATION... 54 A. SCOPE OF SERVICES... 54 B. Organization of the Laboratory Medicine Service... 76 APPOINTMENTS AND REAPPOINTMENTS... 76 A. Medical Staff Membership Requirements... 76 B. Staff Categories... 76 C. Process for Appointments and Reappointments... 76 D. Affiliated Professionals... 76 CLINICAL PRIVILEGES... 87 A. Development of Privilege Criteria... 87 B. Review of Privilege Request Form... 87 C. Change, Addition or Removal of Clinical Privileges... 87 D. Temporary, Visiting, Emergency or Disaster Privileges... 87 PROCTORING AND MONITORING... 87 A. Requirements and Responsibility... 87 B. Ongoing Professional Performance Evaluation (OPPE)... 97 EDUCATION AND RESEARCH... 98 LABORATORY MEDICINE SERVICE RESIDENT TRAINING PROGRAM AND SUPERVISION... 98 A. Description... 108 B. Resident Duties... 108 C. Resident Supervision... 109 D. Resident Evaluation... 1110 E. Ability to Write Patient Orders... 1210 IX. DISCIPLINARY ACTION... 1211 X. LABORATORY MEDICINE PERFORMANCE IMPROVEMENT/PATIENT SAFETY (PIPS) AND UTILIZATION MANAGEMENT... 1211 A. Goals, Objectives... 1211 B. Responsibility... 1311 C. Reporting... 1312 D. Clinical Indicators and Components of the Laboratory Medicine Quality Management Plan... 1312 E. Monitoring & Evaluation of Appropriateness of Patient Care Services and Response to Unusual Occurrence Reports... 1413 XI. MEETING REQUIREMENTS... 1513 XII. ADOPTION, REVIEW AND AMENDMENT... 1614 XIII. REVISION HISTORY... 1715 Page 3 of 31 Med Residency Program\Lab Med Svc R&R 2016.doc

Laboratory Medicine Service Rules and Regulations 2016 September 2016 APPENDIX I LABORATORY MEDICINE PRIVILEGES... 1816 APPENDIX II LABORATORY MEDICINE SERVICE ORGANIZATION CHART... 2220 ATTACHMENT A CLINICAL SERVICE CHIEF S JOB DESCRIPTION... 2721 ATTACHMENT B RESIDENT S PACKET... 3023 ATTACHMENT C ZSFG LABORATORY MEDICINE ROTATIONS... 3124 ATTACHMENT D ZSFG CLINICAL LABORATORY RESIDENTS SURVIVAL MANUAL... 3225 I. LABORATORY MEDICINE SERVICE ORGANIZATION... 2 A. SCOPE OF SERVICES... 2 B. Organization Of The Laboratory Medicine Service... 2 II. APPOINTMENTS AND REAPPOINTMENTS... 2 A. Medical Staff Membership Requirements... 2 B. Staff Categories... 2 Medical staff members on the Laboratory Medicine Service fall into the same two categories, i.e., active and courtesy as described in Article III Categories of the Medical Staff of the SFGH Bylaws, Rules and Regulations.... 2 C. Process for Appointments and Reappointments... 2 D. Affiliated Professionals... 2 III. CLINICAL PRIVILEGES... 2 A. Development of Privilege Criteria... 2 B. Review of Privilege Request Form... 2 C. Change, Addition or Removal Of Clinical Privileges... 2 D. Temporary, Visiting, Emergency Or Disaster Privileges... 2 IV. PROCTORING AND MONITORING... 2 A. Requirements And Responsibility... 2 B. Ongoing Professional Performance Evaluation (OPPE)... 2 V. EDUCATION AND RESEARCH... 2 VI. LABORATORY MEDICINE SERVICE RESIDENT TRAINING PROGRAM AND SUPERVISION... 2 A. Description... 2 B. Resident Duties... 2 C. Resident Supervision... 2 D. Resident Evaluation... 2 E. Ability To Write Patient Orders... 2 IX. DISCIPLINARY ACTION... 2 X. LABORATORY MEDICINE PERFORMANCE IMPROVEMENT/PATIENT SAFETY (PIPS) AND UTILIZATION MANAGEMENT... 2 A. Goals, Objectives... 2 B. Responsibility... 2 Page 4 of 31 Med Residency Program\Lab Med Svc R&R 2016.doc

Laboratory Medicine Service Rules and Regulations 2016 September 2016 C. Reporting... 2 D. Clinical Indicators And Components Of The Laboratory Medicine Quality Management Plan... 2 E. Monitoring & Evaluation Of Appropriateness Of Patient Care Services And Response To Unusual Occurrence Reports... 2 The Director of the Clinical Laboratory will conduct an annual review and approval of the Quality Management (Performance Improvement / Patient Safety) Plan and of the professional practices of the department to assure that they are appropriate and consistent with the plan.... 2 XI. MEETING REQUIREMENTS... 2 XII. ADOPTION, REVIEW AND AMENDMENT... 2 APPENDIX II - LABORATORY MEDICINE SERVICE ORGANIZATION CHART... 2 * Each Headed by Lab Med Faculty / CLS Senior Supervisor... 2 ** Headed by CLS Senior Supervisor... 2 *** Headed by RN... 2 ATTACHMENT A CLINICAL SERVICE CHIEF S JOB DESCRIPTION... 2 ATTACHMENT B RESIDENT S PACKET... 2 ATTACHMENT C - SFGH LABORATORY MEDICINE ROTATIONS... 2 *Held at Laboratory Medicine Service Administrative Office Page 5 of 31 Med Residency Program\Lab Med Svc R&R 2016.doc

June 2013September 2016 LABORATORY MEDICINE SERVICE ORGANIZATION A. SCOPE OF SERVICES The University of California Clinical Laboratory at Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG) ( Clinical Laboratory or Laboratory Medicine Service ) performs more than five hundred varieties of diagnostic laboratory procedures on blood and body fluids, providing routine and emergency (stat) services 24 hours daily, including weekends and holidays. The department has over 150 full- and part-time employees, including physicians, Clinical Laboratory Scientists, specialists and other professional support personnel. Provided services include, but are not limited to the following: 1. Limited phlebotomy services for ZSFG outpatients. 2. Chemical analysis of clinical specimens (routine and special) and clinical consultation. 3. Toxicology testing and clinical consultation. 4. Hematology (routine and special), coagulation studies, urinalysis and clinical consultation. 5. Microbiology studies including bacteriology, mycobacteriology, mycology, virology, parasitology and molecular diagnostics - and clinical consultation. 6. Immunology and serology testing and clinical consultation. 7. Transfusion services, blood product utilization monitoring and clinical consultation. 8. Point-of-care testing (POCT): training of lead POCT personnel, coordination, oversight and maintenance of interdepartmental programs for POCT at ZSFG, including inpatient wards, designated outpatient clinics, Operating Room, Cardiac Catheterization Laboratory, Interventional Radiology Suite, Nursery and Intensive Care Units. Services include consultation, method development, assay validation and verification, coordination of quality control, performance improvement and patient safety, utilization management programs, and related activities. The Laboratory does not oversee POCT programs at off-campus sites, i.ei.e., San Francisco Department of Public Health (SFDPH) health centers and affiliated clinics but offers consultative services on POCT issues to these facilities 9. Laboratory reports: electronic reports generated by the Laboratory Information System (Sunquest, Tucson, AzAZ) and transmitted to the electronic medical record (Lifetime Clinical Record, LCR). Limited printed cumulative and interim reports for laboratory clients without reliable access to the electronic medical record system. 10. Support services, including maintenance of phlebotomy supplies for designated inpatient and outpatient sites, special supplies, sterilization of medical supplies and disinfection of biohazardous waste. 11. Maintenance of an online Laboratory Manual, accessible at http://labmed.ucsf.edu/zsfglab, that provides in-depth information on tests and services provided, specimen requirements, laboratory contacts and other helpful information for Laboratory clients. Page 6 of 31

Age-Specific Specimen and Collection Techniques Laboratory tests are performed and interpreted for patients of all ages, as requested by the clinical care provider or other authorized personnel. Phlebotomy is performed only in the outpatient setting and is generally limited to adults and some pediatric patients in their teens. Blood collection techniques may vary according to the age of the patient and/or the ease of obtaining the specimen, as assessed by the phlebotomist. Patient/Client Needs Assessment Our clients include patients and health care providers at ZSFG, LHH, city jails and outpatient health centers and clinics operated by, or affiliated with the SFDPH. Modification of existing services or provision of new services is based on suggestions or requests from clinical services, results from periodic client satisfaction surveys, new availability of tests, in response to problems uncovered by unusual occurrence reports or informal complaints, and the availability of funding and other required resources. Staffing Plan Each Division within the Clinical Laboratory maintains a standard staffing level based on the type and volume of tests requested. Staffing is flexible in order to accommodate changes in the test workload, clinical practice patterns, patient mix, or other factors. Standards of Practice The Clinical Laboratory at ZSFG strives to serve as a model of excellence for clinical laboratories in urban teaching hospitals, by providing accurate, timely, appropriate and cost-effective laboratory services of the highest quality, in support of the mission of SFDPH and ZSFG. The Laboratory follows the guidelines and standards established by state and federal law and by recognized agencies such as the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO), Clinical and Laboratory Standards Institute (CLSI, formerly known as the National Committee for Clinical Laboratory Standards, or NCCLS), and other professional organizations. ZSFG, through the Laboratory Medicine Service, maintains Associate Active Membership in the Clinical and Laboratory Standards Institute (CLSI). This allows the laboratory director and other members of this department to participate directly in the standards-setting processes of this internationally recognized organization. Reference Laboratories Reference laboratories used by the Laboratory Medicine Service at ZSFG include the following: a. ARUP (Salt Lake City, Utah), one of the nation s leading reference laboratories under contract to perform the bulk of reference laboratory work for ZSFG Page 7 of 31

b. UCSF Clinical Laboratories at Moffitt-Long Hospital and China Basin c. Laboratories of the San Francisco Department of Public Health and other governmental (City and county, state and federal) laboratories d. Commercial reference laboratories under contract to UCSF e. Other reference laboratories as required for special tests and procedures ZSFG Clinical Laboratory is responsible for assuring the quality of work provided by the laboratories to which it refers specimens for testing. The Laboratory Director will recommend annually reference laboratories to be utilized to the Medical ExceutiveExecutive Committee. B. Organization Ofof Thethe Laboratory Medicine Service See Appendix II Laboratory Medicine Service Organization Chart APPOINTMENTS AND REAPPOINTMENTS A. Medical Staff Membership Requirements Membership to the medical staff of Zuckerberg San Francisco General is a privilege which shall be extended only to those practitioners who are professionally competent and continually meet the qualifications, standards, and requirements set forth in ZSFG Medical Staff Bylaws, Article II, Rules and Regulations and these Clinical Service Rules and Regulations. B. Staff Categories B. Medical staff members on the Laboratory Medicine Service fall into the same two categories, i.e., active and courtesy as described in Article III Categories of the Medical Staff of the SFGH Bylaws, Rules and Regulations.Medical staff members on the Laboratory Medicine Service fall into the same two categories, i.e., active and courtesy as described in Article III Categories of the Medical Staff of the ZSFG Bylaws, Rules and Regulations Formatted: Normal, No bullets or numbering Formatted: Normal, Tab stops: 0.75", Left + 0.94", Left Formatted: Normal, Indent: Left: 0" D.C. Process for Appointments and Reappointments The application process for new appointments and reappointments of Laboratory Medicine practitioners to the ZSFG Medical Staff follows ZSFG Bylaws, Rules and Regulations, and these Clinical Service Rules and Regulations. Reappointment is dependent on continuing demonstration of professional conduct and competence. Laboratory Medicine will assist the hospital in this responsibility through ongoing professional performance evaluation of its practitioners (OPPE, see below) and summary evaluations by the Chief and Acting Chief of Service. Page 8 of 31

D. Affiliated Professionals The process of appointment and reappointment to the Affiliated Professionals of ZSFG through the Laboratory Medicine Service is in accordance with ZSFG Bylaws and Rules and Regulations, as well as these Clinical Service Rules and Regulations. CLINICAL PRIVILEGES A. Development of Privilege Criteria Laboratory Medicine Service privileges are developed in accordance with ZSFG Medical Staff Bylaws, Article V: Clinical Privileges. All requests for clinical privileges will be evaluated and approved by the Chief of Laboratory Medicine. Refer to Appendix I. B. Review of Privilege Request Form The Laboratory Medicine Services Privilege Request Form shall be reviewed at least biannually. C. Change, Addition or Removal Ofof Clinical Privileges Laboratory Medicine Service privileges shall be authorized in accordance with the ZSFG Medical Staff Bylaws, Article V: Clinical Privileges. All requests for clinical privileges will be evaluated and approved by the Chief of the Laboratory Medicine Service (synonymous with Director of the Clinical Laboratory ). D. Temporary, Visiting, Emergency Oror Disaster Privileges Privileges in these categories shall be authorized in accordance with the ZSFG Medical Staff Bylaws. PROCTORING AND MONITORING A. Requirements Andand Responsibility Proctoring of newly appointed practitioners and practitioners who acquired new privileges, as well as ongoing monitoring of professional performance of practitioners on the Laboratory Medicine Service shall be in accordance with ZSFG Bylaws, and these service rules and regulations. The Laboratory Medicine Service will assist the medical staff office and credentials committee by proposing relevant indicators, evaluate practitioners and provide evaluations and summary reports, including engaging appropriate evaluators from outside the service, as necessary and required. It is the Page 9 of 31

responsibility of the Chief of Service that proctoring and monitoring requirements are met. B. Ongoing Professional Performance Evaluation (OPPE) The Laboratory Medicine Service monitors the professional performance of its practitionersits practitioners on an ongoing basis using a set of indicators that are developed by the service and approved by the Credentials Committee. The Chief or Acting Chief of Service will evaluate performance profiles of Lab Medicine practitioners at least every 6 months and at the time of reappointment. EDUCATION AND RESEARCH The Laboratory Medicine Service at ZSFG actively participates in and promotes UCSF s academic mission in medical education and research. Graduate and undergraduate medical education and research is conducted in accordance with applicable UCSF and ZSFG administrative policies and procedures and ZSFG Medical Staff Bylaws. The Laboratory Director is accountable to the UCSF s Associate Dean at ZSFG and the Chair of Laboratory Medicine for establishment, supervision, periodic review, and, if necessary, corrective actions of educational and research programs within the Clinical Laboratory. The Laboratory Medicine Service also actively supports professional staff training and education through offering a Clinical Laboratory Scientist (CLS) student internship program in partnership with San Francisco State University, and by maintaining a Continuing Education Program, administered by the Department s Continuing Education Committee under the general direction of the Laboratory Director. This program is approved for State of California Continuing Education credits as authorized by the Continuing Education Accreditation Agency of the UCSF Clinical Laboratory at Zuckerberg San Francisco General, for which the Laboratory Director serves as Administrator. All faculty and staff are encouraged to maintain and enhance their professional skills by attendance at professional meetings and participation in appropriate educational conferences, seminars and courses. LABORATORY MEDICINE SERVICE RESIDENT TRAINING PROGRAM AND SUPERVISION Attending faculty shall supervise house staff in such a way that housestaffhousestaff assume progressively increasing responsibility for patient care according to their level of training, ability and experience. (Refer to CHN Website for Housestaff Competencies at http://in- ZSFGweb01.in.sfdph.net/medicalstaff/). Before starting their rotation residents will be oriented to the Laboratory Medicine Service, provided with a packet of relevant documents including Page 10 of 31

Laboratory Safety Guidelines, and will attest to receipt of these materials (Attachment B: Lab Med Service Resident s Packet) A. Description There are 2-3 Laboratory Medicine Residents assigned at all times to individual rotations within the Laboratory Medicine Services at ZSFG. These rotations are in the Microbiology, Clinical Chemistry/Toxicology, and Hematology/Blood Bank Divisions of the Clinical Laboratory. B. Resident Duties Resident duties differ on each of the rotations but fall into 3 major categories: test approval, test interpretation, and clinical consultation. Detailed information on resident duties for each of the rotations, guidelines for prospective and retrospective review of blood product usage, the recommended management of issues commonly encountered outside of routine working hours, including when to notify attending faculty, are maintained by the Laboratory Medicine Service, reviewed annually and updated as necessary (Attachments C: ZSFG Laboratory Medicine Rotations and D: ZSFG ClinClinicalClan Lab Resident s Survival Manual). C. Resident Supervision Laboratory Medicine (also referred to as Clinical Pathology) residency training is a three year postgraduate program (for Laboratory Medicine only) or two years of a four year combined residency training program in Anatomic Pathology/Clinical Pathology (AP/CP). The UCSF combined AP/CP residency training program or the straight Laboratory Medicine residency training program has flexibility, such that resident competencies and skills are not correlative with year of training. Resident competencies and skills are instead related to type of clinical rotation completed. For example, a resident in his/her final year (4 th ) year of training may be taking a Clinical Microbiology rotation for the very first time in his/her training. In contrast, another resident may have already completed such a rotation in his/her first year of training. Laboratory Medicine residency training at ZSFG consists of three core rotations Microbiology, Chemistry/Toxicology, and Hematology/Blood Bank. Microbiology and Chemistry/Toxicology rotations each last two months, the Hematology/Blood Bank rotation lasts one month. Elective rotations are offered in Toxicology and Consultative Hematology / Transfusion Medicine. Each rotation is supervised by the Chief of the respective Clinical Laboratory Division. The Laboratory Director serves as training site coordinator, ensuring orientation of residents at the beginning of the rotation, appropriate handling and resolution of residency-related issues and maintenance of materials and environment for effective education and learning. Each resident assigned to a rotation in the Clinical Laboratory is closely supervised by the responsible Division Chief during the regular work day. Clinical responsibilities typically consist of test approvals, test interpretations, and clinical consultations. All of these resident functions have direct impact on patient care, as residents make decisions about requests for esoteric testing, interpret laboratory results for diagnostic or Page 11 of 31

therapeutic decisions, and recommend testing strategies for optimum patient management. Initially, all issues and concerns are discussed with and supervised by the respective Division Chief at least daily. The resident assumes more responsibility and independence later in the rotation when s/he has become familiar with the issues unique to each division, is knowledgeable about the policies governing these issues, and the Division Chief has developed confidence in his/her clinical judgment. Laboratory Medicine residents also participate in a variety of clinical conferences (e.g., Medicine s Morbidity and Mortality report, Infectious Diseases conference, Cardiology conference, Endocrinology Conference, Poison Control rounds, etc.). These conferences provide a feedback mechanism by which the residents (and respective Division Chief) can witness the impact of their decisions. These conferences also provide a feedback mechanism for the Clinical Service in general, in which existing Laboratory Medicine policies can be discussed and modified, if necessary. In addition to their daily duties, each Laboratory Medicine Service Resident takes call for all Clinical Laboratory Services at the 4 UCSF teaching hospitals (UCSFMC, Mt. Zion, ZSFG, VAMC) on a rotating basis to provide consultation on laboratory-related issues, approve unusual laboratory tests requests and handle transfusion-related problems arriving outside of routine hours (Mon-Fri 8AM-5PM, Weekends and Holidays). Faculty members provide backup at all times by long range beepers and/or telephone. Disagreements between a clinical service and the Laboratory Medicine Resident are resolved by the faculty member responsible for the service. All situations handled by residents while on-call are logged and reviewed and critiqued weekly via internet video conferencing by Clinical Laboratory faculty from all UCSF teaching sites. Laboratory Medicine residents do not perform invasive procedures, with the exception of bone marrow aspirates / biopsies which would be performed under direct supervision of a Clinical Hematology Fellow or Attending. Some of their duties regarding test utilization or clinical consultation, however, can have serious impact on the acute clinical management and course of the patient (i.e., blood product use, antimicrobial susceptibility test interpretation, etc.). All major decisions having clinical impact are either discussed immediately or reviewed regularly by the responsible Division Chief. D. Resident Evaluation ZSFG Laboratory Medicine residents are evaluated daily by the responsible Division Chief and by all faculty and the Chief of the Service weekly as to their performance while on-call (Friday morning conference). Residents are given constant informal feedback on their performance as well as recommendations for improvement, if necessary. Residents are given a formal in-person evaluation halfway through their rotation, with concrete recommendations for improving their performance if necessary. Residents are formally evaluated at the end of their rotation by the responsible Division Chief. The evaluation is discussed and the discussion documented by checking the appropriate box on the online evaluation form (*e*value). The UCSF Laboratory Medicine Residency Program Director reviews all final evaluations. Copies of all evaluations are available through the Laboratory Medicine Page 12 of 31

Residency Program Director or the Residency Program Coordinator (contact information: phone: 415-353-7359, 185 Berry Street 1036, Suite 100, University of California, San Francisco, San Francisco, CA. 94143 0506). The Director of the Laboratory Medicine Residency Training Program meets with each resident twice annually to review performance, discuss evaluations, and address concerns. E. Ability Toto Write Patient Orders ZSFG Laboratory Medicine residents do not independently write patient orders. VII. CLINICAL LABORATORY FELLOWSHIP PROGRAMS In addition to housestaff training, the Clinical Laboratory offers accredited postdoctorate fellowship education in Clinical Chemistry. and Public Health and Medical Microbiology, respectively. Curriculum development, orientation, supervision and evaluation of fellows is the responsibility of the faculty member overseeing the respective programs, observing UCSF and ZSFG administrative policies and ZSFG Medical Staff Bylaws Rules and Regulations. VIII. LABORATORY MEDICINE SERVICE CONSULTATION CRITERIA Formal or informal professional consultation will be provided upon request for a member of the Medical Staff, professional or administrative personnel of the SFDPH, or other clients of the Laboratory Medicine Service. Such consultations will be provided by Laboratory Medicine residents, fellows, faculty or Clinical Laboratory Scientists, as appropriate. A consultation may also be initiated by the Laboratory Medicine Service if a potential problem is discovered that may adversely affect patient care. IX. DISCIPLINARY ACTION The Zuckerberg San Francisco General Medical Staff Bylaws, Rules and Regulations will govern all disciplinary action involving members of the ZSFG Laboratory Medicine Service. X. LABORATORY MEDICINE PERFORMANCE IMPROVEMENT/PATIENT SAFETY (PIPS) AND UTILIZATION MANAGEMENT Formatted: Indent: Left: 0", First line: 0" A. Goals, Objectives It is the mission of the San Francisco General Hospital Clinical Laboratory to: 1. Perform clinically appropriate laboratory tests for patients at SFGH and for others as authorized by SFDPH or the University of California, 2. Provide accurate and timely reports of laboratory test results; 3. Provide appropriate blood components in a timely manner for effective transfusion; Page 13 of 31

4. Promote the appropriate utilization of Clinical Laboratory resources in order to It is the mission of Zuckerberg San Francisco General Clinical Laboratory to: Provide accurate, timely, efficient, cost-effective and high quality laboratory services in a safe and supportive work environment. Further the UCSF/ZSFG academic missions of research, education, patient care and public service. The department conducts periodic surveys to assess staff and client satisfaction and to identify new or changed needs for tests or services. The term client is used broadly and includesand includes health care providers, patients (inpatients, outpatients, and those within the primary care network), hospital employees and others who interact with the Clinical Laboratory. The department also provides continuing education to housestaff on a regular basis regarding testing procedures, interpretation and optimal utilization of clinical laboratory services. Formatted: Font: 11 pt Formatted: Indent: Left: 1", Hanging: 0.5" Formatted: Font: 11 pt Formatted: Indent: First line: 0" Formatted: Font: 11 pt Formatted: Bulleted + Level: 1 + Aligned at: 1.25" + Indent at: 1.5" Formatted: Font: 11 pt B. Responsibility The Director of the Clinical Laboratory has overall responsibility for the departmental quality management program which includes performance improvement and patient safety activities. The Director and/or designated representative of the Department of Laboratory Medicine attends meetings of the ZSFG Performance Improvement/Patient Safety Committee and participates in the activities of other ZSFG committees as appropriate, in order to promote the performance improvement and patient safety goals of the department and of the hospita1. The Laboratory Manager maintains, coordinates and distributes documents relating to performance improvement and patient safety activities, assures compliance with all laws, rules and regulations, and is responsible for related administrative functions. The Laboratory Manager maintains an index of all policies and procedures pertinent to the Performance Improvement and Patient Safety process, as well as minutes of relevant staff meetings and committee meetings. Division Chiefs and Senior Supervising Clinical Laboratory Scientists within each division, as well as other personnel designated, are responsible for the identification of performance improvement and patient safety issues and the implementation and maintenance of performance improvement and patient safety activities within their areas of expertise and supervision, including the annual review and update of policies and procedures. C. Reporting The Director of the Clinical Laboratory or designated representative provides an annual report to the ZSFG Performance Improvement/Patient Safety and Medical Executive Committees. Page 14 of 31

D. Clinical Indicators Andand Components Ofof Thethe Laboratory Medicine Quality Management Plan The following procedures will be utilized for the evaluation and review of quality and appropriateness of the activities of this department. 1. Quality control results for each test method. 2. Periodic review and update of procedures and policies for special handling, test methods and reports. 3. Quarterly review of reference lab testing for quality and client services at the monthly Clin Lab leadership meeting. 4. Participation in: a. Proficiency testing programs of the College of American Pathologists and/or other providers as appropriate, e.g., the Centers for Disease Control and Prevention, the State of California, and commercial suppliers. b. Other quality improvement programs as appropriate, for example Q-Tracks/Q- Probes programs of the College of American Pathologists. c. Biannual accreditation surveys by The Joint Commission. 5. Case reviews by faculty and house staff of the Laboratory Medicine Service. 6. A variety of pre-analytical and post-analytical test variables specific to each testing discipline that have major impact on patient care (e.g., turnaround testing times for key stat tests, relay of critical test results to clinical care providers, specimen rejection rate, readiness and transport time for blood products, etc.) 7. Regular performance evaluations will be conducted for employees, house staff and faculty according to UCSF and ZSFG policies and procedures, as applicable. E. Monitoring & Evaluation Ofof Appropriateness Ofof Patient Care Services Andand Response Toto Unusual Occurrence Reports The Director of the Clinical Laboratory will conduct an annual review and approval of the Quality Management (Performance Improvement / Patient Safety) Plan and of the professional practices of the department to assure that they are appropriate and consistent with the plan. The Director of the Clinical Laboratory will conduct an annual review and approval of the Quality Management (Performance Improvement / Patient Safety) Plan and of the Formatted: Font: Not Bold Page 15 of 31

professional practices of the department to assure that they are appropriate and consistent with the plan. Unusual Occurrence Reports (UOs), complaints, or issues are investigated and reported in writing as soon as possible. The Director reviews each such incident and a response is forwarded, when appropriate, to the ZSFG Quality MangementManagement Office, other hospital committee, authority, and/or the complaining party. UO Summary reports shall be reviewed at regular meetings of the Clinical Laboratory Leadership to identify UOs that require focused additional review. As issues, patterns and trends are identified, further assessment will be performed to determine the cause and extent of specific problems. The procedures to be followed may include audits of patient charts, pilot studies, research protocols, and interviews with clinical staff. Corrective action may include any of the following, as appropriate: 1. In-service education and training programs for staff, house staff and faculty members. 2. Counseling and proctoring. 3. Staffing changes. 4. Changes in procedures or policies. 5. Changes of reagents and/or equipment. Appropriate utilization of Clinical Laboratory services by the clinical staff will be promoted by formal and informal interaction between Laboratory Medicine faculty and house staff and members of the clinical departments at departmental rounds, house staff conferences, student lectures and seminars, and individual consultations. XI. MEETING REQUIREMENTS In accordance with ZSFG Medical Staff Bylaws, all Active Members are expected to show good faith participation in the governance and quality evaluation process of the Medical Staff by attending a minimum of 50% of all committee meetings assigned, clinical service meetings, including weekly call conferences and the annual Medical Staff Meeting. ZSFG Clinical Laboratory faculty who are not physicians are expected to meet the same attendance requirements as medical staff members, with the exception of attendance at the Annual Medical Staff Meeting. For faculty members with part time clinical appointments the expectation for attendance at meetings is reduced in proportion to their appointment. The leadership of the Laboratory Medicine Service shall meet as frequently as necessary, usually monthly, but at least quarterly to consider findings from ongoing monitoring and evaluation of the quality and appropriateness of the care and treatment provided to patients. As defined in the ZSFG Medical Staff Bylaws, a quorum is constituted by at least three (3) voting members of the Active Staff for the purpose of conducting business. In accordance with the Page 16 of 31

Bylaws, the Laboratory Medicine Service Chief may extend voting rights to non-medical staff members. This will be documented in committee minutes at the beginning of the Medical Staff year and shall remain in effect for one year. XII. ADOPTION, REVIEW AND AMENDMENT Adoption of these Laboratory Medicine Service Rules and Regulations, as well as any revisions or amendments require a majority vote of all active medical staff members and faculty of the Laboratory Medicine Service Department at ZSFG. The Service Chief will conduct a review of these Rules and Regulations at least biannually and propose revisions and amendments to the voting members of the Department. Formatted: Heading 2, Tab stops: Not at 0.5" + 1" + 1.5" + 2" + 2.5" + 3" Page 17 of 31

XIII. REVISION HISTORY Description: Changed review cycle from annual to at least biannual in sections III B. (Review of Privilege Request Form) and XII. (Adoption, review and Amendment). Clarified the review and voting process on revisions and amendments of these service rules and regulations in section XII. Placed in new format. Updated Lab Medicine Service Org Chart. Update references to SFGH LMR Rotation Guideliness (attachments) Changed San Francisco General Hospital (SFGH) to Zuckerberg San Francisco General (ZSFG) throughout Supervisor Signoff By: Signoff Date: E. Fiebig 9/25/2012 E. Fiebig 6/21/2013 Changed Eberhard Fiebig, MD, Director to Barbara Haller, MD, PhD, Interim Director Modified A. Goals and Objectives (Section X) Omit reference to Fellowship education in Public Health Microbiology, section VII Updated Lab Medicine Service Org Chart (Core Lab) B/.Haller 9/1/2016 Deleted reference to Community Health Network, CHN in Clin Lab Director s Job Description Update Attachment B, Resident s Packet Omit reference to Fellowship education in Public Health Microbiology, section VIII Formatted: Heading 2, Tab stops: Not at 0.5" + 1" + 1.5" + 2" + 2.5" + 3" Page 18 of 31

APPENDIX I - LABORATORY MEDICINE PRIVILEGES Privileges for Zuckerberg San Francisco Generall Applicant: Please initial the privileges you are requesting in the Requested column. Service Chief: Please initial the privileges you are approving in the Approved column. FOR ALL PRIVILEGES: All complication rates, problem transfusions, deaths, unusual occurrence reports, patient complaints and sentinel events, as well as any specific Department quality indicators, are monitored semiannually. Formatted: Font: 12 pt Formatted: Font: 12 pt Formatted: Font: 12 pt Requested Approved 16 LABORATORY MEDICINE 16.10 CATEGORY I CORE PRIVILEGES PREREQUISITES: Currently Board Admissible, Board Certified, or Re-Certified by the American Board of Pathology in Clinical Pathology or Anatomic & Clinical Pathology. Patient care responsibilities encompass supervision and direction of the specimen collection, selection of laboratory procedures appropriate for patient care, analysis, reporting and interpretation of results of diagnostic tests, including recommendations for patient management based on these results in Blood Banking /Transfusion Medicine/Immunohematology, Clinical Chemistry, Toxicology, Hematology, Immunology, Microbiology/Virology, Molecular Diagnostics, Medical Informatics and Laboratory Management. PROCTORING: 1) 6 months by the Chief of the Laboratory Medicine Service or Designee. 2) Review of 10 Case Discussions at weekly Lab Med Service Conferences. 3) 6-month review of QC oversight documentation (incl. proficiency testing and quality test management) REAPPOINTMENT: Renewal of privileges requires every 2 years: 1) review of a minimum of 5 Case Discussions at weekly Lab Med Service Conferences 2) review of QC oversight documentation during the evaluation period 16.11 BONE MARROW INTERPRETATION Review and analysis of bone marrow aspirate and biopsy material for diagnosis or monitoring of conditions affecting the hematopoietic system. PREREQUISITES: Currently Board Admissible, Board Certified, or Re-Certified by the American Board of Pathology in Clinical and/or Anatomic Pathology and Hematopathology. Page 19 of 31

PROCTORING: 1) 6 months by the Chief of the Laboratory Medicine Service or Designee. 2) Review of 10 Cases by the Anatomic Pathology Service REAPPOINTMENT: Renewal of privileges requires the review of a minimum of 3 cases by the Anatomic Pathology Service every 2 years. 16.20 CATEGORY II SPECIFIC PRIVILEGES Individuals who do not qualify for core privileges covering all aspects of laboratory medicine may indicate their specific areas of privileging from the list of subspecialties below. Patient care responsibilities within the specific area for which privileges are requested are the same as outlined above for core privileges in Laboratory Medicine. 16.21 BLOOD BANKING, TRANSFUSION MEDICINE, IMMUNOHEMATOLOGY PREREQUISITES: Currently Board Admissible, Board Certified, or Re-Certified by an American Board in Medicine, Pediatrics, Obstetrics/Gynecology, General Surgery or Anesthesia and Blood Banking / Transfusion Medicine. PROCTORING: 1) 6 months by the Chief of the Laboratory Medicine Service or Designee. 2) Review of 10 Transfusion Reaction Reports 3) Review of 10 Case Discussions at weekly Lab Med Service Conferences REAPPOINTMENT: Renewal of privileges requires every 2 years: 1) Review of 5 Transfusion Reaction Reports 2) Review of 5 Case Discussions at weekly Lab Med Service Conferences 3) review of QC oversight documentation during the evaluation period 16.22 CLINICAL CHEMISTRY, TOXICOLOGY PREREQUISITES: Currently Board Admissible, Board Certified, or Re-Certified by an American Board in Chemical Pathology or Clinical Chemistry, Toxicology PROCTORING: 1) 6 months by the Chief of the Laboratory Medicine Service or Designee. 2) Review of 10 Serum/Urine Protein Electrophoresis Reports 3) Review of 10 Case Discussions at weekly Lab Med Service Conferences 4) review of QC oversight documentation during the evaluation period Page 20 of 31

REAPPOINTMENT: Renewal of privileges requires every 2 years: 1) Review of 5 Serum/Urine Protein Electrophoresis Reports 2) Review of 5 Case Discussions at weekly Lab Med Service Conferences 3) review of QC oversight documentation during the evaluation period 16.24 HEMATOLOGY (excluding Bone Marrow Interpretation) PREREQUISITES: Currently Board Admissible, Board Certified, or Re-Certified by an American Board in Clinical Hematology or Hematopathology. PROCTORING: 1) 6 months by the Chief of the Laboratory Medicine Service or Designee. 2) Review of 10 Blood Smear/Body Fluid Interpretations 3) Review of 10 Hemoglobinopathy Interpretations 4) Review of 10 Case Discussions at weekly Lab Med Service Conferences REAPPOINTMENT: Renewal of privileges requires every 2 years: 1) Review of 5 Blood Smear/Body Fluid Interpretations 2) Review of 5 Hemoglobinopathy Interpretations 3) Review of 5 Case Discussions at weekly Lab Med Service Conferences 4) review of QC oversight documentation during the evaluation period 16.25 MICROBIOLOGY / VIROLOGY PREREQUISITES: Currently Board Admissible, Board Certified, or Re-Certified by an American Board in Medical Microbiology. PROCTORING: 1) 6 months by the Chief of the Laboratory Medicine Service or Designee. 2) Review of 10 Broncho-Alveolar Lavage Interpretations 3) Review of 10 Case Discussions at weekly Lab Med Service Conferences REAPPOINTMENT: Renewal of privileges requires every 2 years: 1) Review of 5 Broncho-Alveolar Lavage Interpretations 2) Review of 5 Case Discussions at weekly Lab Med Service Conferences 3) review of QC oversight documentation during the evaluation period Page 21 of 31

========================================================================= Privileges for Zuckerberg San Francisco General I hereby request clinical privileges as indicated above. Applicant Date FOR DEPARTMENTAL USE: Proctor has been assigned for newly granted privileges. Proctoring requirements have been satisfied. Medications requiring DEA certification may be prescribed by this provider. Medications requiring DEA certification will not be provided by this provider. CPR Certification is required. CPR Certification is not required. APPROVED BY: Division Chief Date Service Chief Date Page 22 of 31

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APPENDIX II - LABORATORY MEDICINE SERVICE ORGANIZATION CHART Formatted: Indent: First line: 0.25", Tab stops: 0.5", Left Formatted: Normal Director / Chief of Service UCSF Clinical Laboratory at ZSFG Organizational Chart Showing, Core Lab Leadership Chemistry * Specimen Collection & Management** Hematology* Support Services (Admin, LIS, LS) * Each Headed by Lab Med Faculty / CLS Senior Supervisor ** Headed by CLS Senior Supervisor *** Headed by RN Blood Bank* POCT*** Coordination Microbiology* Formatted: Font: 16 pt Formatted: Normal, Border: Top: (No border) Formatted: Normal Formatted: Font: 16 pt CC, Clinical Consultant TS, Technical Supervisor GS, General Supervisor Page 24 of 31

ATTACHMENT A CLINICAL SERVICE CHIEF S JOB DESCRIPTION University of California, San Francisco Department of Laboratory Medicine Zuckerberg San Francisco General 1001 Potrero Avenue, San Francisco CA 94110 CLINICAL LABORATORYClinical Laboratory DIRECTOR OF CLINICAL LABORATORY, ZUCKERBERG SAN FRANCISCO GENERAL JOB DESCRIPTION: General: The Director of the Clinical Laboratory at Zuckerberg San Francisco General is accountable to the Chairman of the UCSF Department of Laboratory Medicine and the Associate Dean of the UCSF School of Medicine at ZSFG. This individual also serves as Chief of the Laboratory Medicine Service at ZSFG and as Vice Chair for the UCSF Department of Laboratory Medicine at ZSFG. The Director of Clinical Laboratory has overall responsibility for the ZSFG Clinical Laboratory, including direction, planning, implementation and maintenance of all professional and administrative activities, training and educational programs conducted by the Department at ZSFG, as well as any other duties that may be assigned or delegated. Specific responsibilities include, but are not limited to the following: Administrative Responsibilities: Enforces the Medical Staff Bylaws, Rules and Regulations within the Laboratory Medicine Service. Assures compliance with the standards and regulations of the Joint Commission on the Accreditation of Healthcare Organizations, and federal, state and local regulatory agencies. Participates in departmental, hospital-wide, and university-wide activities, including staff meetings, committees, and related functions. Supervises the development, implementation and maintenance of procedures and policies relevant to departmental responsibilities and activities. Assures financial integrity of the department. Directs preparation and justification of annual budgets and assures operation within established budgets. Page 25 of 31

Clinical Responsibilities: Assures that the Clinical Laboratory provide accurate, timely and appropriate laboratory testing, efficiently and cost-effectively. Coordinates and integrates intradepartmental and interdepartmental services with the primary functions of the Community San Francisco Health Network. (CHN). Develops effective procedures to promote professional interaction between the Laboratory Medicine Service and patient-care services for improved patient care. Formatted: Not Highlight Formatted: Not Highlight Formatted: Not Highlight Assures the development, implementation and maintenance of departmental continuing quality improvement programs. Assures that all personnel performing work in or for the ZSFG Clinical Laboratories have the necessary qualifications and competence. Keeps current with and implements emerging technologies as necessary. Academic Responsibilities: As Vice Chair of the UCSF Department of Laboratory Medicine, supervises academic activities at ZSFG, as authorized or delegated by the Department Chair at UCSF and/or the Associate Dean for ZSFG. Assures and provides general supervision for training programs, elective courses and continuing education programs, as appropriate, for house staff assigned to ZSFG, UCSF medical students and technical staff of the ZSFG Clinical Laboratory. Promotes opportunities for continuing education and academic activities, where appropriate, for faculty and staff of the Department of Laboratory Medicine at ZSFG. Maintains competence and leadership in the field of Laboratory Medicine by participation in programs for continuing medical education, professional organizations and public service activities, as appropriate. Approved: Barbara Haller, MD, PhD Interim Director, UCSF Clinical Laboratory at ZSFG Date Page 26 of 31

[Division Chiefs Job Descriptions are held at Laboratory Medicine Service Office] Page 27 of 31

ATTACHMENT B RESIDENT S PACKET Laboratory Medicine Service Resident s Packet Formatted: Font: 14 pt STATEMENT OF RECEIPT: I certify that I have received the Laboratory Medicine Resident s Packet with the following documents enclosed: Please check off: ZSFG Laboratory Safety Guidelines Confidentiality Agreement (Use of DPH Records & Information Systems) ZSFG Housestaff Orientation Manual/ZSFG Clin Lab Resident s Survival Manual Code of Professional Conduct Policy Application for Leave Request Form On-Call Schedule Resident s Weekly Calendar of Conferences Personal Computer Use by ZSFG Laboratory Medicine Residents ** A copy of the Lab Manual is available on the CHN Intranet @ http://insidechnsf.snhsfchnsf.org (left column under Clinical Resources). Field Code Changed Signature: Date: Please complete this form and return to Andy Yeh in the Administration Office as soon as possible. Formatted: Normal Page 28 of 31 Med Residency Program\Lab Med Svc R&R 2016.doc

ATTACHMENT C - ZSFG LABORATORY MEDICINE ROTATIONS UCSF Department of Laboratory Medicine at ZSFG Chemistry/Toxicology Rotation Guidelines (See binder at Chemistry LMR Desk.)* Formatted: Indent: Left: 0", Hanging: 0.31" n* UCSF Department of Laboratory Medicine at ZSFG Hematology/Blood Bank Rotation Guidelines (See Handout, Clinical Microbiology Laboratory Information, provided by Division Chief at orientation.) UCSF Department of Laboratory Medicine at ZSFG Microbiology/Serology Rotation* Guidelines (See handout provided by Division Chief at orientation.) *Held at Laboratory Medicine Service Administrative Office Formatted: Indent: Left: 0.25", No bullets or numbering Formatted: Bulleted + Level: 1 + Aligned at: 0" + Tab after: 0.25" + Indent at: 0.25" Formatted: Indent: Left: 0.5", No bullets or numbering Formatted: Bulleted + Level: 1 + Aligned at: 0" + Tab after: 0.25" + Indent at: 0.25" Page 29 of 31 Med Residency Program\Lab Med Svc R&R 2016.doc

Page 30 of 31 Med Residency Program\Lab Med Svc R&R 2016.doc

ATTACHMENT D - ZSFG CLINICAL LABORATORY RESIDENTS SURVIVAL MANUAL * Formatted: Heading 2, Left, Tab stops: Not at 0.5" + 1" + 1.5" + 2" + 2.5" + 3" *Distributed to each LMR at orientation, copy Hheld at Laboratory Medicine Service Administrative Office Page 31 of 31 Med Residency Program\Lab Med Svc R&R 2016.doc